510(k) · Cleared
ClearedZoll R Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZOLL Medical Corporation · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Cleared on Sep 18, 2008 as substantially equivalent to K060559 (ZOLL Medical Corporation, 2006) after a 105-day review. Its family tree reaches back 8 generations to 1997. 1 of the 31 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Sep 18, 2008
- Review
- 105 days
- Class
- Class II
- Product code
- LDD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K962603 (1997). 22 ancestors in all, the oldest K945071 (1995). 8 later devices descend from it, 1 citing it directly. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 3 generations backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- 2 generations backK042007 Zoll E Series DefibrillatorZoll Medical Corp · 2005 · Recalled
- 1 generation backK060559 Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · Recalled
- This deviceK081574 Zoll R SeriesZOLL Medical Corporation · 2008
- Descendant · cites it directly · 7 of its ownK110361 Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters · 2011
- Descendant · 2 generations on · 6 of its ownK120907 Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012
- Descendant · 3 generations on · 4 of its ownK133269 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014
- Descendant · 4 generations on · 2 of its ownK141774 Zoll X SeriesZOLL Medical Corporation · 2014
- Descendant · 5 generations on · 1 of its ownK202375 ZOLL Propaq MZOLL Medical Corporation · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes4 generations back · 2002
Most influential descendants
Showing 5 of 8 · See all- K110361Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters · 2011 · cites it directly7descendants
- K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · 2 generations on6descendants
- K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014 · 3 generations on4descendants
- K141774Zoll X SeriesZOLL Medical Corporation · 2014 · 4 generations on2descendants
- K202375ZOLL Propaq MZOLL Medical Corporation · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −3 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| −2 | K042007 | Zoll E Series Defibrillator | Zoll Medical Corp | 2005 | 3 |
| −1 | K060559 | Zoll R Series Defibrillator | ZOLL Medical Corporation | 2006 | 1 |
| 0 (this device) | K081574 | Zoll R Series | ZOLL Medical Corporation | 2008 | — |
| +1 | K110361 | Zoll R Series with 2010 Aha Guidelines Software Update | Zoll Medical Corporation, World Wide Headquarters | 2011 | — |
| +2 | K120907 | Zoll R Series | Zoll Medical Corporation, World Wide Headquarters | 2012 | — |
| +3 | K133269 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2014 | — |
| +4 | K141774 | Zoll X Series | ZOLL Medical Corporation | 2014 | — |
| +5 | K202375 | ZOLL Propaq M | ZOLL Medical Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 1 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LDD device
- #1 K200849 Tempus LS - Manualscore 1.3 · 13 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060559 | Zoll R Series DefibrillatorSummary page 2…The features and functions of the proposed R Series with WiFi Option are substantially equivalent to the current features and functions of the R Series (K060559) , cleared for use on 8/17/2006. Comparison of Technological Characteristics The ZOLL R Series with WiFi Option utilizes th… | 2006 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110361 | Zoll R Series with 2010 Aha Guidelines Software Update | 2011 | 7 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 22 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K110361 (Zoll Medical Corporation, World Wide Headquarters, 2011) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K060559.
How does its category compare?
All LDD devicesLDD Dc-Defibrillator, Low-Energy, (Including Paddles): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LDD
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LDD
124in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDD
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDD
74in 2025
MAUDE reports naming product code LDD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 550 |
| 2008 | 2 | — | 11 | 1,214 |
| 2009 | 0 | — | 1 | 1,057 |
| 2010 | 2 | — | 0 | 635 |
| 2011 | 4 | 124 | 1 | 386 |
| 2012 | 0 | — | 0 | 398 |
| 2013 | 0 | — | 0 | 602 |
| 2014 | 1 | — | 2 (2) | 481 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 0 | — | 0 | 58 |
| 2017 | 0 | — | 0 | 49 |
| 2018 | 0 | — | 0 | 28 |
| 2019 | 1 | — | 0 | 34 |
| 2020 | 1 | — | 1 | 19 |
| 2021 | 1 | — | 0 | 22 |
| 2022 | 0 | — | 1 | 80 |
| 2023 | 0 | — | 0 | 264 |
| 2024 | 0 | — | 2 | 160 |
| 2025 | 0 | — | 0 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Defibrillator Function Intended Use - Manual Operation Use of the R Series products in the manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: · Unconsciousness * Absence of breathing * Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac…
Read the full statement (254 words)
Defibrillator Function
Intended Use - Manual Operation
Use of the R Series products in the manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
· Unconsciousness
* Absence of breathing
* Absence of pulse.
This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.
The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above).
Intended Use - Semiautomatic Operatio (AED)
The R Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient.
They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involing CPR, transportation, and definitive care are incorporated into a medically approved patient care protocol.
Use of the R Series in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
• Unconsciousness
· Absence of breathing
* Absence of pulse
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081574 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081574: Zoll R Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081574
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026